Label: GLYCERIN suppository
- NDC Code(s): 52316-725-25, 52316-725-50
- Packager: DSC Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 3, 2021
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- Active ingredient (in each suppository)
For rectal use only
May cause rectal discomfort or a burning sensation.
Ask a doctor before using any laxative if you have
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative formore than 1 week
Stop use and consult a doctor if you have
- rectal bleeding
- no bowel movement after using this product
These symptoms may indicate a serious condition.
- Directions-single daily dosage
- Other information
- Inactive ingredients
- Questions or comments?
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52316-725 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2.1 g Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52316-725-50 50 in 1 JAR; Type 0: Not a Combination Product 04/17/2020 2 NDC:52316-725-25 25 in 1 JAR; Type 0: Not a Combination Product 06/22/2020 12/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/17/2020 Labeler - DSC Laboratories Inc. (097807374) Registrant - DSC Laboratories Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories Inc. 097807374 manufacture(52316-725)